Trackable protective packaging for tools and methods for calibrating tool installation using the same

ABSTRACT

Protective packaging, surgical kits, systems, and methods are described herein for assisting in determining whether a tool is properly installed on a surgical device. The protective packaging retains the tool and has trackable features defined relative to a tool center point of the tool. The trackable features have a predetermined state defined relative to the tool center point and the trackable features are configured to be detectable by a localizer to locate the tool center point. One or more controllers can compare the actual state of the tool center point with an expected state of the tool center point, which is based on an expected condition in which the tool is properly mounted to the surgical device. Based on the comparison, the one or more controllers can determine whether the tool is properly mounted to the surgical device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The subject application claims priority to and all the benefits of U.S.Provisional Patent Application No. 62/820,577, filed Mar. 19, 2019, thecontents of which are hereby incorporated by reference in its entirety.

BACKGROUND

A surgical device, such as a robot, often receives a tool or instrumentfor use during a surgical procedure. The tool may be a cuttingaccessory, such as a saw, bur drill, having a head with sharp featuresconfigured to resect tissue such as bone. Exposed handling of the toolmay result in surgical site infection, injury, and other undesirableconsequences. For these reasons, such tools often require a type ofprotective packaging to prevent inadvertent exposure before and duringinstallation.

A working portion of the tool (e.g., such as the burring portion) mustbe precisely known by the system in order to effect proper control ofthe surgical device. Navigation systems are often utilized with surgicalsystems to track surgical devices, the patient, and additional toolsthat may be utilized in the surgical procedure. The navigation systemoften utilizes markers or trackers that are attached to the objects thatneed to be tracked.

Tool accessories, such as those mentioned above, are interchangeablyinstalled, often operate a high rate of movement and have high exposureto the surgical site thereby requiring sterilization. Therefore, markersor trackers on the tool may negatively affect physical performance ofthe tool or may be impossible to practically implement on the tool.Furthermore, markers on the tool would likely be destroyed duringsterilization. For these reasons, such tool accessories are often notdirectly tracked by the navigation system.

In such situations, there may be no way of knowing whether the tool isproperly installed to the surgical device. There may be situations wherethe tool appears to be properly installed to the operator, when in fact,the tool may be slightly (e.g., by a few millimeters) mis-aligned or notfully seated.

Prior techniques for confirming tool installation require additionalinstruments, such as tracked digitization devices, that are used todigitize certain points on the tool for calibration purposes. However,such techniques require additional tools and operator steps therebyincreasing operating time and costs. Additionally, digitizationtechniques may produce measurements that are less accurate because theprocess requires manual operator involvement in digitizing. For example,the actual digitization point may deviate from the digitization pointexpected by the system.

Another prior method to assess installation accuracy is to use a customend effector for a robotic system whereby the end effector has markersor tracking elements detectable by the navigation system and the toolaccessory is already in a pre-installed, fixed position, relative to theend effector. In such instances, the robot must move to certain poses toimplement a calibration process. In these poses, a kinematic location ofthe robot is known to the system and the locations of the trackingelements on the end effector are compared to the kinematic robotlocations to assess accuracy. However, such methods are not suitable forend effectors that can accept different tools. Furthermore, the endeffector must be customized with the given tool and therefore, thisincreases costs and complexity in end effector versions. Additionally,this technique requires the robot to assume certain poses, therebyincreasing operating room time.

Techniques designed to overcome one or more of the aforementioneddisadvantages are desired.

SUMMARY

In one example, a method for operating a system is provided, the systemcomprising a surgical device and a tool for mounting to the surgicaldevice, the tool including a working portion having a tool center point,a protective packaging for retaining the working portion, the protectivepackaging comprising trackable features having a predetermined statedefined relative to an actual state of the tool center point, one ormore controllers configured to store the predetermined states of thetrackable features and to store an expected state of the tool centerpoint based on an expected condition in which the tool is properlymounted to the surgical device, and a localizer, the method comprising:detecting, with the localizer, actual states of the trackable featuresin a coordinate system; determining, with the one or more controllers,the actual state of the tool center point in the coordinate system basedon the actual states of the trackable features detected by the localizerand the predetermined state of the trackable features defined relativeto the actual state of the tool center point; comparing, with the one ormore controllers, the actual state and expected state of the tool centerpoint; and evaluating, with the one or more controllers, whether thetool is properly mounted to the surgical device based on comparing theactual state and expected state of the tool center point.

In another example, a system is provided. The system comprising: asurgical device; a tool configured to mount to the surgical device andcomprising a working portion having a tool center point; a protectivepackaging configured to retain the working portion of the tool, theprotective packaging comprising trackable features having apredetermined state defined relative to an actual state of the toolcenter point; one or more controllers coupled to the surgical device andconfigured to store the predetermined states of the trackable featuresand to store an expected state of the tool center point based on anexpected condition in which the tool is properly mounted to the surgicaldevice; and a localizer coupled to the one or more controllers and beingconfigured to detect actual states of the trackable features in acoordinate system; and wherein the one or more controllers areconfigured to: determine the actual state of the tool center point inthe coordinate system based on the actual states of the trackablefeatures detected by the localizer and the predetermined state of thetrackable features defined relative to the actual state of the toolcenter point; compare the actual state and expected state of the toolcenter point; and evaluate whether the tool is properly mounted to thesurgical device based on comparing the actual state and expected stateof the tool center point.

In another example, a protective packaging for a tool is provided,wherein the tool includes a working portion and a tool center pointassociated with the working portion, the protective packagingcomprising: a distal section defining a cavity configured to retain theworking portion; and the distal section comprising trackable features,wherein the trackable features have a predetermined state definedrelative to a state of tool center point, and the trackable features areconfigured to be detectable by a localizer for enabling the localizer tolocate the tool center point.

In another example, an assembly for a surgical procedure is provided,the assembly comprising: a tool including a working portion and a toolcenter point associated with the working portion; and a protectivepackaging that retains the working portion, and wherein the protectivepackaging comprises trackable features, wherein the trackable featureshave a predetermined state defined relative to the tool center point andthe trackable features are configured to be detectable by a localizerfor enabling the localizer to locate the tool center point.

BRIEF DESCRIPTION OF THE DRAWINGS

Advantages of the present disclosure will be readily appreciated as thesame becomes better understood by reference to the following detaileddescription when considered in connection with the accompanying drawingswherein:

FIG. 1 is a perspective view of a protective packaging for retaining atool in accordance with one example.

FIG. 2 is a plan view of the protective packaging of FIG. 1 furtherillustrating trackable features on the packaging and their relationshipto a tool center point of the tool.

FIG. 3 is an example system comprising a navigation system utilized inconjunction with a surgical device, in this example, the end effector ofa robotic manipulator which is configured to receive the tool retainedby the packaging, and further illustrates relationships betweencomponents of the system that can be known or determinable by one ormore controllers to determine the state of the tool center point of thetool.

FIG. 3A is an expanded view of the packaging and tool from FIG. 3further illustrating the relationship between the trackable features andthe tool center point.

FIG. 4 illustrates one example of surgical device and the one or morecontrollers wherein an expected tool center point of the tool known tothe one or more controllers is illustrated in a hypothetical conditionwherein the tool is properly installed to the surgical device.

FIG. 5 illustrates the surgical device of FIG. 4 wherein the packagedtool is improperly installed to the surgical device, and wherein the oneor more controllers compares the expected tool center point from FIG. 4to an actual state of the tool center point to determine an errorcondition.

DETAILED DESCRIPTION

Described herein are trackable protective packages for tools, andsystems and methods for tracking the protective packaging for variouspurposes, such as to confirm installation of the tool to a surgicaldevice.

A. Examples of Protective Packaging for Tools

Referring to FIG. 1 , a non-limiting example of a protective packaging22 is illustrated. The protective packaging 22 is specifically shaped toaccommodate and retain a tool 24 and provides safe, sterile and securehandling of the tool 24 during storage, transport, and mounting of thetool 24 on a surgical device 28 (see FIGS. 3 and 5 ). In view of thetechniques described below, having the protective packaging 22 beutilized during or after mounting of the tool 24 on the surgical device28 provides significant advantages.

The protective packaging 22 and its uses during tool 24 installation canbe like those described in US Pat. App. Pub. No. 2018/0296297A1,entitled “Packaging Systems and Methods for Mounting A Tool on ASurgical Device”, the disclosure of which is hereby incorporated byreference in its entirety. However, the protective packaging 22 can havedifferent configurations from the protective packaging 22 shown.

In one example, the tool 24 is a device that is configured to removematerial from a target site, such as a bone of a patient, soft tissue,or the like. For these reasons, the tool 24 is likely to be a sharpobject. The tool 24 can also be a passive object, i.e., a purelymechanical object having no actively energizable electrical components.Examples of tools 24 include, but are not limited to burs, drill bits,screw drivers, saws, and the like.

The tool 24 comprises a working portion W or energy applicator. Theworking portion W is a feature of the tool 24 that is configured tointeract with and manipulate the target site. When the tool 24 is a bur,the working portion W is the bur head 26 rigidly coupled to a tool shaft25 (as shown). When the tool 24 is a drill bit, the working portion Wcan be the threaded portion of the drill shaft or a distal tip of thedrill bit. When the tool 24 is a saw, the working portion W can be adistal tip or teeth of the saw blade. For simplicity in description, thetool 24 described in the examples below is a bur and the working portionis the bur head 26. However, various other tools 24 with differentworking portions W are fully contemplated to be utilized with thetechniques described herein.

The surgical device 28 may be any apparatus configured to receive andoperate the tool 24. In other words, the surgical device 28 may provideactuation, control, power, etc., to the tool 24. The surgical device 28of FIGS. 3-5 is a surgical robot R having an end effector configured toreceive the tool 24. In this example, the surgical device 28 can be therobot R and/or the end effector. Other example combinations of the tool24 and the surgical device 28 are contemplated. For example, possiblecombinations may include: a saw or a blade configured to be received bya saw driver; a router, a curved bur, or a sleeve connector for a burconfigured to be received by a handheld rotary instrument; electrodesconfigured to be received by a smoke evacuation pencil; a scalpelconfigured to be received by a scalpel handle; an ultrasonic tipconfigured to be received by an ultrasonic aspirator; and an endoscopicshaver or cutter configured to be received by an endo-handpiece. For anyof the example above, the surgical device 28 can be a hand-heldinstrument configured to be supported (against the force of gravity) andmanually moveable in space by the hand and arm of a user. It is to beunderstood that other surgical devices for receiving tools arecontemplated. As will be described below, the tool 24 and/or surgicaldevice 28 according to any configuration may be tracked by a navigationsystem.

In one example, the tool 24 includes a distal region 27 and anattachment portion 29. The working portion W is at the distal region 27of the tool 24 and the attachment portion 29 is the part of the tool 24that installs to the surgical device 28. In some instances, theattachment portion 29 is located a proximal region of the tool 24,opposite the distal region 27. At the distal region 27 is a distal end30 and at the attachment region 29 is a proximal end 32 of the tool 24.A length of the tool 24 can be defined between the distal end 30 and theproximal end 32. If the tool 24 is symmetrical about an axis ofrotation, a tool axis may be defined between the distal end 30 and theproximal end 32.

In this example, the protective packaging 22 provides a casing thatcomprises a distal section 34 that has a cavity to retain the distalregion 27 of the tool 24 to protect the operator and preventcontamination. The distal section 34 may comprise distal portions 36, 38that collectively retain the tool 24. The distal portions 36, 38 can beseparate components or can be integrally formed as one component. Thedistal portions 36, 38 may be pivotably coupled to one another such thatthey can open and close, in a clamshell configuration. In such examples,the distal section 34 can be opened to enable removal of the tool 24from the protective packaging 22 and closed to enable retention of the24 in the protective packaging 22. In other examples, the distalportions 36, 38 can be permanently coupled together, such as by using ahigh frequency weld, adhesive, integrally formed material, etc. In suchexamples, the protective packaging 22 can be configured to slide overand off the tool 24.

In some examples, the protective packaging 22 can have only the distalsection 34. In other examples, such as that shown in FIG. 1 , theprotective packaging 22 can optionally include a proximal section 40that couples to the distal section 34. The proximal section 40 can beprovided with a cavity to retain the proximal end of the tool 24, suchas the tool shaft 25. The proximal section 40 can be pivotably coupledto the distal section 34 at a hinge 42. This hinge 42 enables theproximal section 40 to be detached from the tool shaft 25 simultaneouslywhile remaining hinged to the distal section 34. This way, the toolshaft 25 can be exposed for installation while the proximal section 40can provide shielding protection for the operator's hand. In otherexamples, the hinge may comprise a perforation 44 that enables theproximal section 40 to be detached completely from the distal section34.

Importantly, the protective packaging 22 provides a low dimensionaltolerance and/or tight mechanical fit when retaining the tool 24.Features may be designed into the tool 24 and/or the protectivepackaging 22 to achieve the fit. For example, a hole could be placed ina saw blade with a mating protrusion in the protective packaging 22, oran undercut could of a drill shaft could be used to align with aprotrusion in the protective packaging 22. As will be described below,the tight tolerance securely retains the tool 24 while providing a knownrelationship between features of the protective packaging 22 (e.g.,trackable features) and the tool 24. In one example, the dimensionaltolerance is less than 1 mm or even less than 0.1 mm. Any suitablecasing of the protective packaging 22 is contemplated that protect theoperator and prevent contamination while maintaining a tight mechanicalretention of the tool 24. Hence, the casing of the protective packing 22is not limited to the examples described herein.

The protective packaging 22 may comprise, in part or entirely, materialsuch as polyethylene terephthalate glycol-modified (PETG). Othersuitable materials may include, without limitation, polymers such aspolyethylene terephthalate (PET), high-density polyethylene (HDPE),polyvinyl chloride (PVC), low-density polyethylene (LDPE), polypropylene(PP), and polystyrene (PS), epoxy and other resins, and malleable metalssuch as aluminum. The protective packaging 22 can be formed bythermoforming, injection molding, vacuum molding, blow molding, or othermanufacturing processes.

Various different configurations of the protective packaging 22 arecontemplated. For example, the protective packaging 22 can behermetically sealed (against liquid and gas). The protective packaging22 can be reusable (sterilizable) or disposable (single use). Theprotective packaging 22 can have features, such as texturized features,to enable the operator to easily grip the protective packaging 22 fortool 24 installation or to open and close the distal portions 36, 38.The protective packaging 22 or any of its components can be adjustablein size or dimension, and can be elastic, flexible, or deformable. Theprotective packaging 22 can be tool 24 specific or generically usablefor different tools. As will be described below, the protectivepackaging 22 can also have features that enable the protective packaging22 to be detectable and/or to avoid being detectable.

The protective packaging 22 can be used for initial attachment of thetool 24 to the surgical device 28 or it can be used for re-attachment ofthe tool 24 during the surgical procedure. There may be a need tore-check the position of the tool 24 during the procedure or the tool 24may be removed for a portion of the procedure and later re-installed.The protective packaging 22 can have any combination of the featuresdescribed herein and can have configurations or features other thanthose described herein.

B. Trackable Features for the Protective Packaging

As shown in the non-limiting example of FIGS. 1 and 2 , the protectivepackaging 22 can comprise one or more trackable features T. Thetrackable features T can be utilized to track the tool 24 when the tool24 is retained by the protective packaging 22. The trackable features Tcan also be utilized to track the protective packaging 22 when the tool24 is not retained therein. In another example, described below, thetrackable features T are utilized to determine whether or not the tool24 is properly mounted/installed to the surgical device 28.

The protective packaging 22 may comprise any number and anyconfiguration of trackable features T. In this example, three trackablefeatures T1-T3 are provided with the protective packaging 22. Having atleast three trackable features T provides the ability to know theposition and orientation of the protective packaging 22. The trackablefeatures T can be placed on or affixed to the protective packaging 22utilizing any suitable technique. Alternatively, the trackable featuresT can be integrally formed on, in, or with the protective packaging 22.For example, the trackable features T can be embedded within thematerial of the protective packaging 22. The trackable features T canalso be uniquely identifiable features integral to the protectivepackaging 22, such as edges, protrusions, recesses, shapes or any of thecomponents of the protective packaging 22 described herein.

The trackable features T can be passive or actively energized and can beof any appropriative type of detectable configuration. The trackablefeatures T may be infrared trackable features. When infrared, thetrackable features T can be retroreflective elements or LED emitters,for example. Alternatively or additionally, the trackable features T canbe passive landmarks, patterns, and/or shapes that are uniquelyidentifiable. The trackable features T can also be configured withpatterns, colors, gradients, and/or texturized materials. In otherexamples, the trackable features T can be passive or active magnetic orelectro-magnetic elements, passive or active radio frequency elements,radio-opaque elements, ultrasound detectable elements, or anycombination of the above-described configurations.

The trackable features T can be provided on the protective packaging 22in any location, manner, or configuration. For example, the trackablefeatures T can be positioned the first and/or second distal portions 36,38. The trackable features T can also be positioned on the proximalsection 40. In one example, the trackable features T are provided onlyon the distal section 34, but not the proximal section 40. Thisconfiguration is based on the practical consideration that the workingportion W of the tool 24 will remain retained by the distal section 34during tool 24 installation, whereas the proximal section 40 may bedetached from the protective packaging 22 or otherwise pivoted relativeto the distal section 34 prior to installation. Furthermore, thetrackable features T can be positioned on one side or multiple sides ofthe protective packaging 22, including any of the top, bottom, or leftor right sides, as needed, to enable the trackable features T to bedetectable.

In another example, each of the first and second distal portions 36, 38comprises an exterior surface, which is exposed when the protectivepackaging 22 is closed. In this example, one or more trackable featuresT can be coupled to the exterior surface of at least one of the firstand second distal portions 36, 38. As such, the trackable features T canbe readily visible when the protective packaging 22 is closed.

In yet another example, the trackable features T may comprisesub-components on different parts of the protective packaging 22. Forexample, each of the first and second distal portions 36, 38 comprisesan interior surface. The interior surfaces engage each other when theprotective packaging 22 is closed. In this example, one or moretrackable features T comprise a first component coupled to the interiorsurface of the first distal portion 36 and a second component coupled tothe interior surface of the second distal portion 38. The first andsecond components are positioned such that when the protective packaging22 is closed, the first and second components engage or combine to formthe trackable feature T. In other words, the trackable feature T may befunctional when the protective packaging 22 is fully closed andnon-functional when the protective packaging 22 is partially or entirelyopen. The first and second components can be electrical, magnetic, orlayers of material (e.g., reflective material) that work together toform the trackable feature T when the protective packaging 22 is closed.The trackable features T can also extend through the material of theprotective packaging 22 such that the trackable feature T is on both theexterior and interior surfaces of the protective packaging 22.

The protective packaging 22 may comprise a material that is transparentto light. The transparent material can increase visibility and/or reduceretro-reflectivity of the protective packaging 22 to increase accuracyin detecting the trackable features T. When transparent, visible lightpenetration through the protective packaging 22 material may be greaterthan 75%, 90%, or 95%. The protective packaging 22 can also be equippedwith surface properties or features to reduce retro-reflectivity.Examples of such properties or features include, but are not limited to,rough surfaces, dimpled surfaces, anti-reflective coating or film, orthe like.

The trackable features T and the configuration of the protectivepackaging 22 can be different than the examples described above.

C. Example Navigation Systems

To implement tracking of the trackable features T, a navigation system100 is provided, as shown in FIG. 3 , for example. The navigation system100 can be utilized in conjunction with the surgical device 28. As shownin FIG. 3 , for example, the surgical device 28 is the end effector ofthe robot R that is configured to receive the tool 24.

The navigation system 100 is configured to track movement of variousobjects. Such objects include, for example, the protective packaging 22,the robot R, the surgical device 28 and the anatomy of a patient. Thenavigation system 100 tracks these objects with respect to a(navigation) localizer coordinate system LCLZ. Coordinates in thelocalizer coordinate system LCLZ may be transformed to the robot(manipulator) coordinate system MNPL, and/or vice-versa, usingtransformation techniques described herein.

One example of the navigation system 100, surgical robot, controltechniques, and transformations associated therewith, which can beutilized with the techniques herein, is described in U.S. Pat. App. Pub.No. 2018/0168750A1 filed on Dec. 13, 2017, entitled, “Techniques formodifying tool operation in a surgical robotic system based on comparingactual and commanded states of the tool relative to a surgical site,”the entire disclosure of which is hereby incorporated by reference.

The navigation system 100 may include a cart assembly 102 that housesthe one or more controllers 104, such as a navigation computer, and/orother types of control units. The one or more controllers 104 may alsobe located in the surgical device 28 and/or a cart of the robot R. Theone or more controllers 104 may be located in components or subsystemsother than that shown in FIG. 3 and may be implemented on any suitabledevice or devices in the system 100 other than the configuration shown.In one example, the controllers for the navigation system and the robotare two different controllers performing different operations, and canbe configured, for example, as described in U.S. Pat. App. Pub. No.2018/0168750A1. The one or more controllers 104 can comprise softwareand/or hardware configured to perform all the tasks described herein.Example of hardware may comprise processors, CPUs, microprocessors,integrated circuits, non-transitory memory, graphic processing units,hard drives, and input/output devices.

A navigation interface is in operative communication with the one ormore controllers 104. The navigation interface includes one or moredisplays 106. The one or more controllers 104 is capable of displayinggraphical (actual or virtual) representations of the relative states ofthe tracked objects to the operator using the one or more displays 106.As will be described below, alerts, notifications, or error messages canalso be represented on one or more of the displays 106.

In addition to the trackable features T described with respect to theprotective packaging 22, the other objects tracked by the navigationsystem 100 include one or more trackers or trackable features. In oneexample, as shown, the trackers may include a tool tracker 108 attachedto surgical device 28 (e.g., end effector), a robot tracker 109 attachedto the base of the robot R (as shown) or to one or more links of therobot R, and target site trackers (not shown), which can be attached toa patient. Any one or more of the trackers may include active or passivetrackable features, and may be used with any tracking modality describedherein.

The navigation system 100 also includes a navigation localizer 110(hereinafter “localizer”) that tracks a state of trackable features T onthe protective packaging 22, and other trackers or trackable features.As used herein, the state of an object includes, but is not limited to,data that defines the position and/or orientation of the tracked objector equivalents/derivatives of the position and/or orientation. Forexample, the state may be a pose of the object, and may include lineardata, and/or angular velocity data, and the like. The localizer 110provides the state of these tracked objects to the one or morecontrollers 104 to enable the one or more controllers 104 to makedeterminations based on such information.

In one example, as shown in FIG. 3 , the localizer 110 is an opticallocalizer and includes a camera unit 112 with one or more opticalsensors 114. The localizer 110 can be an infrared based localizersuitable for detecting trackable features T that are configured withactive or passive infrared elements. Although one embodiment of thenavigation system 100 is shown in FIG. 3 , the navigation system 100 mayhave any other suitable configuration for tracking the trackablefeatures T.

Additionally, or alternatively, the localizer 110 can be a machinevision system, The machine vision system can comprise a camera that isconfigured to detect trackable features T that can include patterns,shapes, colors, textures, gradients and/or uniquely identifiablefeatures provided by the protective packaging 22. The machine visionsystem can employ various types of imaging and imaging processingmodalities, such as 2D/3D visible light imaging, depth maps, pixelanalysis, edge detection, pattern recognition, and the like. One exampleof a machine vision system that can be utilized is described in USPublication No. 2017/0143432A1, entitled, Systems and Methods forEstablishing Virtual Constraint Boundaries,” the entire contents ofwhich are incorporated by reference herein.

In another example, the navigation system 100 and/or localizer 110 areradio frequency (RF)-based. For example, the navigation system 100 maycomprise an RF transceiver in communication with the one or morecontrollers 104. The trackable features T of the protective packaging 22may comprise RF emitters or transponders. The RF emitters ortransponders may be passive or actively energized. The RF transceivertransmits an RF tracking signal and generates state signals to the oneor more controllers 104 based on RF signals received from the RFemitters. The one or more controllers 104 may analyze the received RFsignals to associate relative states thereto. The RF signals may be ofany suitable frequency. The RF transceiver may be positioned at anysuitable location to effectively track the objects using RF signals.Furthermore, the RF emitters or transponders may have any suitablestructural configuration that may be much different than the trackers ortrackable features as shown in the Figures.

The navigation system 100 and/or localizer 110 can also beelectromagnetically based. For example, the navigation system 100 maycomprise an EM transceiver coupled to the one or more controllers 104.The trackable features T of the protective packaging 22 may comprise EMcomponents, such as any suitable magnetic tracker, electro-magnetictracker, inductive tracker, or the like. The trackable features T may bepassive or actively energized. The EM transceiver generates an EM fieldand generates state signals to the one or more controllers 104 basedupon EM signals received from the trackers. The one or more controllers104 may analyze the received EM signals to associate relative statesthereto. Again, such navigation system 100 embodiments may havestructural configurations that are different than the navigation system100 configuration as shown throughout the Figures.

In another example, the navigation system 100 and/or localizer 110 areultrasound-based. For example, the navigation system 100 may comprise anultrasound imaging device coupled to the one or more controllers 104.The ultrasound imaging device images any of the aforementioned objects,e.g., the protective packaging 22 and/or trackable features T generatestate signals to the one or more controllers 104 based on the ultrasoundimages. For example, the ultrasound imaging device may be a portabledevice whose position is tracked. The portable device can be positionedproximate to any object to track the object. The one or more controllers104 may process the images in near real-time to determine states of theobjects. The ultrasound imaging device may have any suitableconfiguration and may be different than the camera unit 112 as shown inFIG. 3 .

The navigation system 100 and/or localizer 110 may be based on anycombination of the tracking modalities above and may have any othersuitable components or structure not specifically recited herein.Furthermore, any of the techniques, methods, and/or components describedabove with respect to the camera-based navigation system 100 shownthroughout the Figures may be implemented or provided for any of theother embodiments of the navigation system 100 described herein.

D. Tool Center Point and Relationship to Protective Packaging

According to the techniques described herein, the trackable features Tof the protective packaging 22 are utilized to track the tool 24 whenthe tool 24 is retained by the protective packaging 22. Morespecifically, the navigation system 100 can track the trackable featuresT to determine whether or not the tool 24 is properly mounted/attachedto the surgical device 28.

To help facilitate this technique, the protective packaging 22 providesa low dimensional tolerance and tight mechanical fit when retaining thetool 24. Furthermore, the protective packaging 22 is involved with theprocess of installing the tool 24 to the surgical device 28. Therefore,tracking the protective packaging 22 to determine whether or not thetool 24 is properly mounted/attached to the surgical device 28 providesthe advantages of reducing steps and reducing additional devices in theoperating room. Furthermore, the tight tolerance provides measurementswith a high degree of accuracy as compared with prior techniques. Thetight tolerance provided by the protective packaging 22 enables thetechniques herein to treat the protective packaging 22 as a virtualextension of the tool 24 geometry for calibration or verificationpurposes. By providing tracking features on the protective packaging 22,permanent tracking features on the tool 24 (particularly near theworking portion) can be avoided. Avoiding permanent tracking features onthe tool 24 is advantageous since permanent tracking features on a tool24 can interfere with tool 24 operation or with the surgical site andcannot be located proximate enough to working portion of the tool 24since the working portion is utilized to manipulate the anatomy. On theother hand, the protective packaging 22 is installed on the workingportion, and hence, maximizes the calibration and verificationmeasurement capability to the distal-most portion of the tool 24.Furthermore, the methods described herein provide a seamless userexperience, as accuracy checks can be done without adding externalcomponents or steps.

Referring to FIG. 2 , the tool 24 comprises a tool center point (TCP),which in one embodiment, is a predetermined reference point defined atthe working portion W or relative to the working portion W. In oneembodiment, the TCP is assumed to be located at the center of aspherical of the tool 24 such that only one point is tracked. The TCPmay relate to a bur having a specified diameter. Often, the TCP isdefined at a location that is at a center of the working portion W. Forexample, as shown in FIG. 2 , the TCP is located at the spherical centerof the bur. However, this may not always be the case. For example, theTCP of a drill bit can be a point in the cylindrical center of thedrill, but located anywhere along the tool shaft 25. Similarly, for asaw blade, the TCP can be located anywhere on the saw blade. The TCP canalso be arbitrarily defined somewhere with respect to the workingportion W. Therefore, the term “center” is not limited to thegeometrical center of the working portion W. The TCP may be definedaccording to various manners depending on the configuration of theworking portion W.

Furthermore, the TCP can be a physical point on the working portion W orthe TCP can be a virtual point. In either instance, the one or morecontrollers 104 is configured to store the predetermined TCP staterelative to known geometry for the specified tool 24. Aside from thetechniques described herein for confirming installation of the tool 24,the TCP can also be utilized by the one or more controllers 104 tofacilitate control of the tool 24 and/or surgical device 28. Forexample, such control can be movement of the tool 24 relative to virtualboundaries or tool paths. Examples of TCPs and uses thereof incontrolling surgical devices can be like those described in US Pat. App.Pub. No. 2018/0168750A1, entitled “Techniques for modifying tooloperation in a surgical robotic system based on comparing actual andcommanded states of the tool relative to a surgical site,” the entirecontents of which are hereby incorporated by reference.

In instances where the tool 24 is not directly tracked by the navigationsystem 100, the state of the working portion W relative to the surgicaldevice 28 or relative to the navigation system 100 may not be known.Advantageously, when the tool 24 is retained by the protective packaging22, the actual state of the TCP can be determined since the protectivepackaging 22 has trackable features T. As used herein, the “actual”state of the TCP is the real position and/or orientation of the TCP inphysical 3D space or in a global coordinate system. In one example, thisglobal coordinate system is the localizer coordinate system LCLZ. Tofacilitate this determination, the trackable features T are specificallypositioned on the protective packaging 22 with a predetermined statedefined relative to the actual state of the TCP. The one or morecontrollers 104 is configured to store these predetermined states of thetrackable features T relative to the actual state of the TCP for furtherevaluations, as will be described below.

Prior to tracking, the actual state of the TCP can be assumed in thecorrect state relative to the trackable features T based on theunderstanding that the tool 24 is properly retained by the protectivepackaging 22. Mainly, the various features of the protective packaging22 described above (e.g., tight mechanical fit) help to ensure that thetool 24 is properly retained relative to the protective packaging 22 soas to validate this assumption.

As shown in the example in FIG. 2 , the trackable features T1-T3 (inthis case, passive markers) and the actual state of the TCP can bedefined in a common coordinate system (e.g., the coordinate system ofthe protective packaging 22). In this example, the actual state of theTCP can be considered the origin of the coordinate system, and thecenter of each trackable feature T is utilized for the coordinatemeasurements. However, it is not necessary to define the actual state ofthe TCP at the origin of the coordinate system nor to utilize the centerof each trackable feature T for measurement.

In FIG. 2 , an X-axis and Y-axis define the coordinate system, where Xand Y are distances relative to the origin TCP. There may also be Z-axiscoordinates (in and out of the page of FIG. 2 ) that can be consideredin this coordinate system. Z-axis coordinates would be appropriate ifany of the trackable features T are defined on a different planerelative to the actual state of the TCP or relative to each other. Forsimplicity in description and illustration, the Z-axis coordinates areomitted on the assumption that the trackable features T are coplanarwith the actual state of the TCP. However, the manner in which theZ-axis coordinates are determined can be like that described hereinrelative to the X and Y-axis coordinates.

Here, trackable feature T1 is defined at −X1, Y1 relative to the actualstate of the TCP, trackable feature T2 is defined at −X1, −Y3 relativeto the actual state of the TCP, and trackable feature T3 is defined atX1, Y2, relative to the actual state of the TCP. The coordinatemeasurements and trackable feature T placement relative to the actualstate of the TCP in FIG. 2 is only one example. Of course, the trackablefeatures T can have other predetermined states relative to the actualstate of the TCP depending on factors such as the nature of the TCP, thetypes and positions of the trackable features T, and the structure ofthe protective packaging 22, etc.

E. Techniques for Evaluating Tool Installation with Tracked Packaging

Referring back to FIG. 3 , the navigation system 100 is shown with thetool 24 coupled to the surgical device 28. The operator installs thetool 24 to the surgical device 28 by holding the protective packaging22. In this example, it is assumed that an attempt was made to installthe tool 24 to the surgical device 28, however, the operator may not beaware whether the tool 24 is properly installed.

As can be understood from the example of FIG. 2 , the state of theactual TCP is known relative to the states of the trackable features T.As will be described below, the trackable features T of the protectivepackaging 22 and this known relationship are utilized by the navigationsystem 100 and one or more controllers 104 for determining whether thetool 24 is properly mounted/installed to the surgical device 28.

To facilitate this determination, the navigation system 100 is shownwith various transforms (T) for determining the actual state of the TCPin a global coordinate system, e.g. LCLZ. The transform (T), whencalculated, gives the state (position and/or orientation) of a firstcomponent in its respective coordinate system relative to the state of asecond component in its respective coordinate system. The one or morecontrollers 104 calculates/obtains and combines a plurality oftransforms (T) from the various components of the system, e.g., forpurposes such as to validate installation of the tool 24 and/or tocontrol the surgical device 28 or robot R when the tool 24 is installed.The transforms (T) are computational determinations but are representedin FIG. 3 by arrows between the subject components for illustrativepurposes. The directionality of the arrow head is not intended to limitthe direction of the transform. In other words, the transform (T) cangive the state of one component with respect to the other, or viceversa.

In one embodiment, each transform (T) is specified as a transformationmatrix, such as a 4×4 homogenous transformation matrix. Thetransformation matrix, for example, includes three unit vectorsrepresenting orientation, specifying the axes (X, Y, Z) from a firstcoordinate system expressed in coordinates of a second coordinate system(forming a rotation matrix), and one vector (position vector)representing position using the origin from the first coordinate systemexpressed in coordinates of the second coordinate system.

Example systems and methods for obtaining and computing transforms ofthe various components of the system is explained in U.S. Pat. No.9,119,655, entitled, “Surgical Manipulator Capable of Controlling aSurgical Instrument in Multiple Modes,” and U.S. Pat. App. Pub. No.2018/0168750A1 filed on Dec. 13, 2017, entitled, “Techniques formodifying tool operation in a surgical robotic system based on comparingactual and commanded states of the tool relative to a surgical site,”the entire disclosures of which are hereby incorporated by reference.

As shown in FIG. 3 , the transforms include a first transform (T1)between the localizer 110 and trackable features T of the protectivepackaging 22 and a second transform (T2) (best shown in FIG. 3A) betweenthe trackable features T and the actual state of the TCP. Othertransforms that may be utilized include a third transform (T3) betweenthe localizer 110 and the surgical device 28 tracker 108, a fourthtransform (T4) between the surgical device 28 tracker 108 and areference point on the surgical device 28, a fifth transform (T5)between the actual state of the TCP and the reference point on thesurgical device 28, and/or a sixth transform (T6) between the referencepoint on the surgical device 28 and a base of the robot (R).

Transforms (T1) and (T3) are obtained using tracking data from thelocalizer 110. In other words, the localizer 110 tracks the state of thetrackable features T of the protective packaging 22 and the state of thesurgical device 28 tracker 108 relative to the LCLZ coordinate system.Transform (T2) is obtained based on the known relationship between thetrackable features T of the protective packaging 22 and the actual stateof the TCP of the tool 24 retained by the protective packaging 22, asdescribed in the prior section. Transform (T4) is obtained based on aknown relationship between the surgical device 28 tracker 108 and thereference point on the surgical device 28. Transform (T5) is obtainedbased on a known relationship between an expected state of the TCP(i.e., the state of the TCP when the tool 24 is installed properly,which will be described further below) and the reference point on thesurgical device 28. Transform (T6) can be determined based on kinematicdata of the robot (R) stored by the one or more controllers 104 withoutintervention from the navigation system 100. Alternatively oradditionally, transform (T7) can be obtained by localizer 110determining the relationship between the surgical device 28 tracker 108and the tracker 109 at the base of the robot R. Not all of thesetransforms (T) may be utilized in every instance, and these transforms(T) can be utilized in various combinations.

Any known relationship data (e.g., for transforms T2, T4 or T5) isstored by the one or more controllers 104 and may be fixed (constant orstatic) or variable. In embodiments where the known relationship data isfixed, the known relationship data may be derived from calibrationinformation relating to the respective components (e.g., the surgicaldevice 28, the surgical device 28 tracker 108, and the expected state ofthe TCP). For example, the calibration information may be obtained at amanufacturing/assembly stage, e.g., using coordinate measuring machine(CMM) measurements, etc. The known relationship data may be obtainedusing any suitable method, such as reading the known relationship datafrom a computer-readable medium, an RFID tag, a barcode scanner, or thelike. The known relationship data may be imported into system 100 at anysuitable moment such that the known relationship data is readilyaccessible by the one or more controllers 104. In embodiments where theknown relationship data is variable, the known relationship data may bemeasured or computed using any ancillary measurement system orcomponents, such as additional sensors, trackers, encoders, or the like.The known relationship data may also be acquired after mounting thesurgical device 28 tracker 108 to the surgical device 28 in preparationfor a procedure by using any suitable technique or calibration method.

With reference to FIGS. 4 and 5 , the one or more controllers 104 isconfigured to evaluate the information described above to determinewhether the tool 24 is properly mounted to the surgical device 28. Forexample, the one or more controllers 104 can determine whether or notthe TCP is in the proper position and take action in response.

In FIG. 4 , the one or more controllers 104 is configured to store theexpected state of the TCP based on an expected condition in which thetool 24′ is properly mounted to the surgical device 28. The expectedstate of the TCP is a virtual state (e.g., point) stored in one or morecontrollers 104 memory rather than a physical state on the tool 24itself. For this reason, a dotted representation of the tool 24′ isshown in FIG. 4 to represent the expected state of the TCP during anassumed proper installation. Furthermore, in FIG. 4 , a properinstallation line 120 is shown within the tool receiving portion of thesurgical device 28 to illustrate one example of where a proximal end 32of the tool 24 should be relative to the surgical device 28 when thetool 24′ is properly installed. In this illustration, the hypotheticaltool 24′ is fully seated within the surgical device 28 (and henceproperly installed) such that the proximal end 32 of the tool 24′ alignswith line 120.

This installation representation is for simplicity in description andillustration, and tool 24′ installation schemes will vary depending onthe type of tool being installed and the configuration of the surgicaldevice 28. Hence, the use of an “installation line” 120 is not intendedto limit the nature of proper installation conditions. Indeed, theproper installation between the tool 24 and the surgical device 28 maybe defined by any suitable number of reference datum having anycomplexity designated by the respective installation scheme.Additionally, or alternatively, proper installation may be defined byany suitable physical parameter measured between the tool 24 and thesurgical device 28, wherein the physical parameter can be correlatedwith, compared to, or otherwise associated to physical parametersderivable from the trackable features of the packaging 22 and the TCP.Such physical parameters may include, but not limited to: position,magnitude of displacement, distance, orientation, linear motion orvelocity, angular motion or velocity, inertial parameters, forceparameters, displacement parameters, pressure parameters, torqueparameters. Hence, instead of comparing the expected state of the TCP tothe actual state of TCP based on static position, the techniques may beutilized to compare an expected motion of the TCP during expected properinstallation to actual motion of the TCP during actual installation.Accordingly, the term “state” is not intended to be limited to a staticmoment in time, but may encompass a period of time. Hence, the term“state” can be static or dynamic.

Furthermore, the installation scheme between the tool 24 and thesurgical device 28 may include any suitable sensing devices, includingbut not limited to, direct (DC) electrical connection sensors, proximitysensors, hall effect sensors, electromagnetic sensors, radio frequencysensors, inductive sensors, capacitive sensors, and the like. Thesesensors are not intended to replace the techniques described herein, butrather can optionally be utilized in conjunction with the techniquesdescribed herein, for purposes such as tool identification, coarse toolinstallation, or tool presence detection.

The expected state of the TCP can be locally derived from the describedknown relationship data for transform T5, which can obtained using anymanner described above. Additionally, or alternatively, the expectedstate of the TCP can be based on separate known relationship dataobtained about the relationship between the expected state of the TCPand any other portion of the surgical device 28, such as the portionthat receives the tool 24. For any given pose of the robot R or state ofthe surgical device 28, the one or more controllers 104 can determinethe expected state of the TCP based on combining the transforms (T)described above. For example, the expected state of the TCP can bedetermined by combining any one of the following combinations:(T3+T4+T5), (T5+T6), (T5+T6+T7), etc.

If/when the tool 24 is properly installed, the expected TCP and theactual TCP states should be identical. Otherwise, if the tool 24 isimproperly installed, the expected TCP and the actual TCP states will bedifferent. Additionally, the trackable features may be different fordifferent tools 24. This will allow the system to further identify thetool 24 being used and/or confirm the correct tool is used.

FIG. 5 illustrates the actual installation condition of the tool 24relative to the surgical device 28. In this situation, the tool 24 isimproperly mounted to the surgical device. This error condition isillustrated by distance d between the proximal end 32 of the tool 24 andthe proper installation line 120. In other words, the tool 24 is notfully seated in the surgical device 28. The distance d can be difficultto detect to the human eye, e.g., 1 mm or less. Hence, the tool 24 isnot properly installed, but may appear so to the operator. Although theerror condition is represented by distance d in this example, it ispossible that the error condition can take other forms depending on thenature of the tool 24, the surgical device 28, and/or manner ofinstallation. For example, the error condition can be an identificationof an incorrect tool, improper rotation, linear position, orientation,damage to the tool, or any combination thereof. Regardless of the natureof the error condition, the techniques described herein are configuredto detect the error.

Since the tool 24 is improperly installed in FIG. 5 , the state of theactual TCP differs from the state of the expected TCP. In this example,the error condition (distance d) at the proximal end 32 of the tool 24causes a corresponding gap d between the actual TCP and expected TCPstates. Of course, other error conditions are possible. For example, ameasured distance of the tool 24 that is offset with the tool insertionaxis could indicate the tool 24 is damaged or is the incorrect tool.

The one or more controllers 104 can make this determination by obtainingthe state of the actual TCP using the transforms (T) described above.Regardless of the pose of the robot R or the state of the surgicaldevice 28, the one or more controllers 104 can determine the actual TCPstate based on combining transformations (T1+T2). In other words, theactual state of the TCP is known to the one or more controllers 104 bythe tracked state of the trackable features T of the protectivepackaging 22 and the predetermined states of the trackable features (T)defined relative to the actual state of the TCP. The one or morecontrollers 104 can arrive at the actual and expected TCP states bycombining other combinations of transformations other than thosespecifically described.

Knowing the states of the actual and expected TCPs, the one or morecontrollers 104 can compare them using any suitable method, such ascomparing position/orientation matrix data from the transforms, etc. Incertain examples, different transformation combinations can be comparedto validate comparison results. For example, the state of the actual TCPcan be validated in the LCLZ coordinate system by comparing the trackingdata of the surgical device 28 tracker 108 (transform T3) with thetracking data of the trackable features T on the protective packaging 22(transform T1).

If the one or more controllers 104 determines that the states of theactual and expected TCPs, are different, the one or more controllers 104may instruct generation of a notification or alert to inform theoperator of the error condition. The alert or notification can be visualand provided on the display 106, as shown in FIG. 3 . The alert can alsobe audible or haptic. Based on the nature of the error conditiondetermined by the one or more controllers 104, the one or morecontrollers 104 can issue specific instructions about how to resolve theerror condition given the circumstance. For example, the one or morecontrollers 104 may generate a notification instructing the operator to“fully insert the tool shaft” or “rotate the tool shaft 180 degreesclockwise”. At any point, the one or more controllers 104 can re-assessthe states of the actual and expected TCPs and inform the operator thatthe tool 24 is properly installed if the results of the comparison arefavorable.

If the expected TCP state is different from the actual TCP state, thesystem may propose a decision process. For example the system may askthe user to confirm the correct tool is used, the system may suggest theuser replace a damaged tool, and/or the user could instruct the systemto accept the position of the actual state of the TCP and use thelocation for the remainder of the surgical procedure.

In certain instances, the one or more controllers 104 can be configuredwith a tolerance or threshold or range of error or acceptance whenevaluating the differences between the states of the actual and expectedTCPs. For instance, the one or more controllers 104 can have a toleranceof +/−0.1 mm such that if the states of the actual and expected TCPs areoff by less than 0.1 mm, the one or more controllers 104 cannevertheless determine that the tool 24 is properly installed. Thetolerance may be different from the value given, depending on manyfactors, such as the mechanical stack-up of components of the system,the nature of the installation, the accuracy of the localizer 110, orthe like. If the actual state of the TCP falls within acceptable rangeof the expected state of the TCP tolerance, the state of the actual TCPcan be stored by the one or more controllers 104 as the calibrated TCPstate that will be used for controlling the surgical device 28.

Several embodiments have been discussed in the foregoing description.However, the embodiments discussed herein are not intended to beexhaustive or limit the invention to any particular form. Theterminology which has been used is intended to be in the nature of wordsof description rather than of limitation. Many modifications andvariations are possible in light of the above teachings and theinvention may be practiced otherwise than as specifically described.

What is claimed is:
 1. A method for operating a system comprising asurgical device and a tool for mounting to the surgical device, the toolincluding a working portion having a tool center point, a protectivepackaging for retaining the working portion, the protective packagingcomprising trackable features having a predetermined state definedrelative to an actual state of the tool center point, one or morecontrollers configured to store the predetermined states of thetrackable features and to store an expected state of the tool centerpoint based on an expected condition in which the tool is properlymounted to the surgical device, and a localizer, the method comprising:detecting, with the localizer, actual states of the trackable featuresin a coordinate system; determining, with the one or more controllers,the actual state of the tool center point in the coordinate system basedon the actual states of the trackable features detected by the localizerand the predetermined state of the trackable features defined relativeto the actual state of the tool center point; comparing, with the one ormore controllers, the actual state and expected state of the tool centerpoint; and evaluating, with the one or more controllers, whether thetool is properly mounted to the surgical device based on comparing theactual state and expected state of the tool center point.
 2. The methodof claim 1, wherein the localizer is an infrared camera and at least oneof the trackable features comprises a passive infrared element or activeinfrared element, and further comprising the infrared camera detectingthe actual state of the at least one of the trackable features bydetecting an infrared signal reflected by the passive infrared elementor radiated by the active infrared element of the at least one of thetrackable features.
 3. The method of claim 1, wherein the localizer is amachine vision system and at least one of the trackable featurescomprises a predetermined pattern, shape or color, and furthercomprising the machine vision system detecting the actual state of theat least one of the trackable features by detecting the predeterminedpattern, shape or color of the at least one of the trackable features.4. The method of claim 1, further comprising the localizer tracking astate of the surgical device in the coordinate system and furthercomprising the one or more controllers determining the expected state ofthe tool center point in the coordinate system by combining the trackedstate of the surgical device in the coordinate system and knownrelationship data between the expected state of the tool center pointand a predetermined reference point on the surgical device.
 5. Themethod of claim 1, further comprising the step of mounting the tool tothe surgical device by grasping the protective packaging.
 6. A methodfor operating a system comprising a surgical device and a tool formounting to the surgical device, the tool including a working portionhaving a tool center point, a protective packaging for retaining theworking portion, the protective packaging comprising trackable featureshaving a predetermined state defined relative to an actual state of thetool center point, one or more controllers configured to store thepredetermined states of the trackable features and to store an expectedstate of the tool center point based on an expected condition in whichthe tool is properly mounted to the surgical device, and a localizer,the method comprising: detecting, with the localizer, actual states ofthe trackable features in a coordinate system; determining, with the oneor more controllers, the actual state of the tool center point in thecoordinate system based on the actual states of the trackable featuresdetected by the localizer and the predetermined state of the trackablefeatures defined relative to the actual state of the tool center point;comparing, with the one or more controllers, the actual state andexpected state of the tool center point; evaluating, with the one ormore controllers, whether the tool is properly mounted to the surgicaldevice based on comparing the actual state and expected state of thetool center point; and instructing, with the one or more controllers,generation of at least one of a haptic, audible, and visual alert inresponse to evaluating whether the tool is properly mounted to thesurgical device.
 7. A system comprising: a surgical device; a toolconfigured to mount to the surgical device and comprising a workingportion having a tool center point; a protective packaging configured toretain the working portion of the tool, the protective packagingcomprising trackable features having a predetermined state definedrelative to an actual state of the tool center point; one or morecontrollers coupled to the surgical device and configured to store thepredetermined states of the trackable features and to store an expectedstate of the tool center point based on an expected condition in whichthe tool is properly mounted to the surgical device; and a localizercoupled to the one or more controllers and being configured to detectactual states of the trackable features in a coordinate system; andwherein the one or more controllers are configured to: determine theactual state of the tool center point in the coordinate system based onthe actual states of the trackable features detected by the localizerand the predetermined state of the trackable features defined relativeto the actual state of the tool center point; compare the actual stateand expected state of the tool center point; and evaluate whether thetool is properly mounted to the surgical device based on comparing theactual state and expected state of the tool center point.
 8. The systemof claim 7 wherein the localizer is an infrared camera and at least oneof the trackable features comprises a passive infrared element or activeinfrared element, and further comprising the infrared camera beingconfigured to detect the actual state of the at least one of thetrackable features by being configured to detect an infrared signalreflected by the passive infrared element or radiated by the activeinfrared element of the at least one of the trackable features.
 9. Thesystem of claim 7, wherein the localizer is a machine vision system andat least one of the trackable features comprises a predeterminedpattern, shape or color, and further comprising the machine visionsystem being configured to detect the actual state of the at least oneof the trackable features by being configured to detect thepredetermined pattern, shape or color of the at least one of thetrackable features.
 10. The system of claim 7, wherein the localizer isfurther configured to track a state of the surgical device in thecoordinate system and wherein the one or more controllers are furtherconfigured to determine the expected state of the tool center point inthe coordinate system by combining the tracked state of the surgicaldevice in the coordinate system and known relationship data between theexpected state of the tool center point and a predetermined referencepoint on the surgical device.
 11. The system of claim 7, wherein theprotective packaging comprises: a distal section defining a cavityconfigured to retain the working portion of the tool; a proximal sectioncoupled to the distal section and defining a cavity configured toreceive an attachment portion of the tool, and wherein the proximalsection is detachable from the distal section by a perforation; andwherein the distal section comprises the trackable features.
 12. Asystem comprising: a surgical device; a tool configured to mount to thesurgical device and comprising a working portion having a tool centerpoint; a protective packaging configured to retain the working portionof the tool, the protective packaging comprising trackable featureshaving a predetermined state defined relative to an actual state of thetool center point; one or more controllers coupled to the surgicaldevice and configured to store the predetermined states of the trackablefeatures and to store an expected state of the tool center point basedon an expected condition in which the tool is properly mounted to thesurgical device; and a localizer coupled to the one or more controllersand being configured to detect actual states of the trackable featuresin a coordinate system; and wherein the one or more controllers areconfigured to: determine the actual state of the tool center point inthe coordinate system based on the actual states of the trackablefeatures detected by the localizer and the predetermined state of thetrackable features defined relative to the actual state of the toolcenter point; compare the actual state and expected state of the toolcenter point; evaluate whether the tool is properly mounted to thesurgical device based on comparing the actual state and expected stateof the tool center point; and instruct generation of at least one of ahaptic, audible, and visual alert in response to evaluating whether thetool is properly mounted to the surgical device.